Medical containers generally must be sterile, have a low level of non-viable particulate matter and have a low or undetectable pyrogen level prior to the introduction of medication or another medical product into the medical container such that the product is not contaminated. One having ordinary skill in the art will realize that the medical containers are not necessarily completely sterile and free of all pyrogens prior to being filled with a medical product. However, the medical containers may be referred to as being sterile, pyrogen free and non-viable particulate matter free, meaning that the medical containers have a high sterility, a low or non-pyrogenic level and a low level of non-viable particulate matter. Common medical containers, for example, vials and syringes, are typically shipped from the vial or syringe molder in a permeable, non-sterile package and are sterilized, washed and depyrogenated to reduce pyrogen levels before introduction into a vial or syringe filling assembly line.
Glass vials and syringes may be washed and heated to a predetermined temperature for a predetermined time to eliminate non-viable particulate matter, reduce pyrogen levels and sterilize the vials and syringes. This process is relatively simple for a manufacturer who fills vials or syringes to perform because the glass vials and syringes are relatively easy to wash and place into a heated oven for the predetermined time. However, polymeric or plastic vials and syringes are typically unable to withstand the temperature required to reduce pyrogens to a non-pyrogenic level and sterilize the vials and syringes. The plastic vials and syringes may be washed and irradiated to reduce pyrogens and sterilize the vials and syringes, but the plastic vials and syringes are difficult to dry and the process is time consuming and generally will not result in removal of pyrogens to an acceptable level for filling. Accordingly, it would be advantageous to ship plastic vials and syringes directly from the vial and syringe molder that are sterile and pyrogen free during and after their shipment. Shipment of sterilized plastic vials and syringes to the assembly line would eliminate the extra sterilization, pyrogen reduction and non-viable particulate matter reduction processes that must be performed. In addition, vials and syringes are typically sterile, have a low pyrogen level and a low non-viable particulate matter level when they come out of a molding process and it would be advantageous to ship the vials and syringes in this condition without impacting their sterility, low pyrogen level and low non-viable particulate level.
Medical containers are typically shipped in boxes, trays or other like shipping containers that are permeable, not sterile and have a relatively high level of pyrogens. In addition, the shipping containers are often utilized to hold the medical containers in an orderly fashion in a clean room such that a robot is able to pick the medical containers out of the shipping containers and place them onto an assembly line. Accordingly, in order to enter the clean room environment, the shipping containers must also be sterile, have a low non-viable particulate matter level and have a low pyrogen level. Therefore, the shipping containers must also be sterilized, depyrogenated and cleaned of particulate matter before they enter the clean room. It would be advantageous to directly ship sterile, pyrogen free and non-viable particulate matter free medical containers in a sterilized, pyrogen free and non-viable particulate matter free container that may be taken directly to a clean room for filling of the medical containers.
Further, when medical containers are shipped in permeable boxes or trays in permeable bags, the vials and syringes may shift or vibrate during their shipment. When the vials and syringes shift and/or vibrate during transport, they may rub against each other causing surface damage and potentially introducing particulates into the bag and onto the vials and syringes. Accordingly, it would be advantageous to ship the vials and syringes in a package that generally does not permit significant shifting, movement or vibration of the vials and syringes, thereby resulting in reduced damage to the vials and syringes during shipping.